Regulatory Affairs Manager (Hybrid)

PE Global is currently recruiting for a Regulatory Affairs Manager for a leading multi-national pharmaceutical client based in Runcorn.

This is an initial 6 month contract with strong possibility of extension or to move to a permanent position within the company.

Provide Technical Leadership and Management of Regulatory Teams through coordination of resources across new product submission, site maintenance and regulatory compliance at the client’s Runcorn facility.

Role:

• Resource Management to monitor and control central spend in line with agreed budget.
• Project Management to plan, resource and coordinate the delivery of projects to support the achievement of product launches and variations.
• Coordination of meetings with Global and Regional teams to discuss strategies and resolve issues
• Interfaces with the site (R&D and Operations authors) to ensure regulatory strategies are integrated into site projects
• Support the preparation of regulatory filings, as needed
• Identification of issues and factors that may implicate a regulatory strategy or activity
• Responsible for the strategy and execution of the site specific aspects of the preparation of CMC amendments and post market supplements
• The flexibility to understanding of the commercial objectives of the business, coupled with an ability to challenge, independently and constructively, senior management, peers or other staff where appropriate, to insist upon adherence to the highest standards of business practice and to the requirements of relevant authorities. Tact and sensitivity as well as strength and authority are important
• Ability to use initiative and work with minimum supervision but ensuring, at the same time, that the line reports are kept fully informed at all times
• Ability to consider issues from a range of angles and propose creative solutions that assist the business in achieving its goals in a safe, compliant and controlled manner
• Ability to communicate effectively, orally and in writing, with senior internal and external audiences – to educate, persuade, negotiate, gain decisions, enforce
• Ability to influence senior management
• Working cross functionally with site and with external Partners including, Quality, Commercial, Medical and Legal teams.
• Working with the different Regulatory Agencies and with UK Government on-site registration/ inspection for handling of Controlled Substances.
• Good understanding of the drug product life-cycle from development to product launch
• Maintains current knowledge of regulatory guidance’s and importance of keeping up to date to regulatory changes and interpreting its implication at the drug development and commercial stage.
• Good Coaching skills to lead and mentor development of the regulatory teams
• Flexible to appreciate commercial objectives for the business.
• Good project management skills with the ability to oversee multiple projects simultaneously
• Responsible for the strategy and execution of site specific changes in the preparation of CMC amendments and post market supplements
• Ability to communicate effectively, orally and in writing, with internal departments and external partners and with Regulatory Agencies audiences
• Develop robust regulatory plans working with different stakeholders to ensure that high quality submission packages are approved on time to ensure site business objectives are achieved
• Evaluate changes in regulatory environment and standard. Conduct gap analysis and implementation plans to assure compliance to latest requirements
• Effective in communicating with top level management and competent authorities
• Strategic thinking as well as hands-on experience with different registration procedures including the US, EU and IMT regions

Requirements:

• Minimum Qualification/Experience degree in Chemistry or Life Sciences.
• Extensive regulatory knowledge in pharma environments in the US, EU and IMT markets.
• Knowledge of cGMP regulatory requirements of pharma products/ development processes in drug product steriles. Line Management, and or budgetary accountability

Interested candidates should submit an updated CV.

Please click the link below to apply or alternatively send an up to date CV to Jennifer.horgan@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***